Phase 3
N=819
A Study of Belimumab in Subjects With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT00410384 ↗Enrolled (actual)
819
Serious AEs
21.7%
Results posted
May 2011
Primary outcome: Primary: SLE Responder Index (SRI) Response Rate at Week 52 — 33.5; 40.6; 43.2 Percentage of participants — p=0.0167
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Belimumab 1 mg/kg (Drug); Belimumab 10 mg/kg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Human Genome Sciences Inc.
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SLE Responder Index (SRI) Response Rate at Week 52 |
33.5; 40.6; 43.2 | 0.0167 sig |
| SECONDARY SRI Response Rate at Week 76 |
32.4; 39.1; 38.5 | 0.1323 |
| SECONDARY Percent of Subjects With a ≥ 4 Point Reduction From Baseline in SELENA SLEDAI Score at Week 52. |
35.3; 42.8; 46.5 | 0.0063 sig |
| SECONDARY Mean Change in Physician's Global Assessment (PGA) at Week 24. |
-0.49; -0.47; -0.44 | 0.7962 |
| SECONDARY Mean Change From Baseline in Medical Outcomes 36-Item Short Form Health Survey (SF-36) Physical Component Summary Score (PCS) at Week 24. |
3.35; 3.78; 3.21 | 0.6583 |
| SECONDARY Percent of Subjects Whose Average Prednisone Dose Has Been Reduced by ≥ 25% From Baseline to ≤ 7.5 mg/Day During Weeks 40 Through 52 |
12.7; 19.2; 17.5 | 0.4253 |
Summary
The purpose of this study is to evaluate the efficacy, safety, tolerability, and impact on quality of life of two different doses of belimumab administered in addition to standard therapy in subjects with active, autoantibody-positive systemic lupus erythematosus (SLE) disease.
Eligibility Criteria
Key Inclusion Criteria
- Clinical diagnosis of SLE by ACR criteria.
- Active SLE disease.
- Autoantibody-positive.
- On stable SLE treatment regimen.
Key Exclusion Criteria
- Pregnant or nursing
- Have received treatment with any B cell targeted therapy.
- Have received treatment with a biological investigational agent in the past year.
- Have received IV cyclophosphamide within 180 days of Day 0.
- Have severe lupus kidney disease.
- Have active central nervous system (CNS) lupus.
- Have required management of acute or chronic infections within the past 60 days.
- Have current drug or alcohol abuse or dependence.
- Have a historically positive test or test positive at screening for HIV, hepatitis B, or hepatitis C.
Data sourced from ClinicalTrials.gov (NCT00410384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.